Job Description
De functie
Biotech Process Engineer
Draag bij aan de continue verbetering van innovatieve biotech productieprocessen !
Ben jij een ervaren biotech professional met een passie voor procesverbetering, data-analyse en technische innovatie? Wil je een sleutelrol spelen in het optimaliseren van productieprocessen binnen een hoog gereguleerde GMP-omgeving? Dan is deze functie als Biotech Process Engineer bij Organon in Oss een mooie volgende stap.
Jouw impact: Als Biotech Process Engineer lever je specialistische ondersteuning bij complexe onderzoeken, proceswijzigingen, technologieoverdrachten.
Daarnaast ben je verantwoordelijk voor het definiëren, initiëren en realiseren van product- en procesverbeteringen binnen onze biotech productieomgeving. Je vertaalt procesinzichten en data naar concrete verbeterinitiatieven en zorgt ervoor dat processen duurzaam, compliant en efficiënt blijven presteren.
Over de afdeling: Biotech maakt deel uit van de Pharmaceutical Technical Operations Internal (PTOi) organisatie. Vanuit deze rol werk je nauw samen met andere afdelingen van PTOi, Integrated Process Teams (IPT's), Quality, Chemical Technical Operations (CTO) en Analytical Sciences.
Verantwoordelijkheden
In deze rol:
Ontwikkel en realiseer je verbeteringen van bestaande productieprocessen en producten op basis van data-analyse en procesinzichten.
Ben je verantwoordelijk voor de uitvoering en opvolging van het Continuous Process Validation (CPV) programma voor toegewezen producten.
Initieer, leid of ondersteun je multidisciplinaire verbeterprojecten binnen de biotech organisatie.
Vertaal je verbetervoorstellen naar studieplannen inclusief planning, mijlpalen en benodigde resources.
Interpreteer je studieresultaten en procesdata en zet deze om naar concrete verbeteracties.
Stel je protocollen, technische rapportages en procesdocumentatie op of beoordeel je deze.
Lever je specialistische ondersteuning bij complexe product- en procesonderzoeken.
Beoordeel en ondersteun je change controls met betrekking tot processtandaardisatie en procesverbeteringen.
Ondersteun je nieuwe productintroducties, technologieoverdrachten en wijzigingen in registratiedossiers.
Werk je nauw samen met wereldwijde technische netwerken om best practices en innovaties te implementeren.
Vereiste opleiding, werkervaring en vaardigheden
Je bent een analytische en ondernemende professional die complexe technische vraagstukken weet te vertalen naar praktische verbeteringen. Je combineert sterke inhoudelijke expertise met overtuigingskracht en kunt effectief schakelen tussen operators, engineers, management en internationale stakeholders.
Daarnaast beschik je over:
Een afgeronde BSc- of MSc-opleiding in Biotechnologie, Procestechnologie, Life Sciences of vergelijkbaar.
Minimaal 5 jaar relevante ervaring binnen biotech productie en/of biotechnologische projecten. Ervaring in Upstream Processing en/of Downstream Processing is een grote pre.
Uitgebreide kennis van GMP-richtlijnen en compliance-eisen.
Ervaring met procesverbetering, validatie en data-gedreven besluitvorming.
Een Go-to-Gemba mentaliteit en een hands-on aanpak.
Sterke communicatieve vaardigheden en het vermogen om stakeholders op verschillende niveaus mee te nemen in verandering.
Goede beheersing van zowel Nederlands als Engels, mondeling en schriftelijk.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Skills Required
- Bachelor’s or master’s degree in Biotechnology, Process Technology, Life Sciences, or a comparable field
- At least 5 years of relevant experience in biotech manufacturing and/or biotechnological projects
- Experience with upstream processing and/or downstream processing
- Extensive knowledge of GMP guidelines and compliance requirements
- Experience with process improvement, validation, and data-driven decision-making
- Go-to-Gemba mentality and hands-on approach
- Strong communication skills and ability to engage stakeholders at different levels during change
- Fluent Dutch and English, spoken and written
Organon Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Organon and has not been reviewed or approved by Organon.
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Strong & Reliable Incentives — Quarterly bonuses and performance-based long-term incentives are frequently emphasized as meaningful components of total rewards, sometimes contrasted favorably with larger pharmaceutical firms. Recognition programs and an annual incentive process reinforce a pay-for-performance approach.
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Parental & Family Support — Twelve weeks of gender-neutral paid parental leave and twenty days of bereavement leave, including coverage for pregnancy loss, signal a robust family support offering. Caregiving concierge services and flexible leave practices further strengthen support for caregiving needs.
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Retirement Support — Retirement plans include employer contributions across many markets, with U.S. materials highlighting matching and additional company retirement contributions. This structure is presented as a core part of the financial benefits package.
Organon Insights
What We Do
Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).
